What is the BtX Designation Program?

The European Medicines Agency (EMA) plans to launch a pilot programme for the EU Breakthrough Device (BtX) designation in the second quarter of 2026, as posted on the EMA Medical Device main page January 12, 2026. This pilot follows the approach laid out in the MDCG 2025-9 guidance document, released by the Medical Device Coordination Group (MDCG) in December 2025 entitled “Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746.”

For manufacturers of novel devices that can make a significant impact to patient health, the goal of the program is to offer a path to streamlined and potentially faster market entry without sacrificing the rigour around ensuring safety and performance.

Breakthrough designation is meant for manufacturers of medical devices regulated under MDR 2017/745 and in vitro diagnostic devices (IVDs) regulated under IVDR 2017/746 that meet the defined criteria. This blog outlines the BtX criteria, how to obtain designation, the advantages of having BtX designation, and other considerations for manufacturers from the BtX guidance. In this discussion, the focus will be more on medical devices rather than IVDs.

BtX Criteria

For a medical device or IVD to be considered for breakthrough designation status, it must meet the following criteria, as defined by the MDCG guidance document.

1. Novelty
   The device introduces a high degree of novelty with respect to the device technology, the related clinical procedure, and/or the application of the device in clinical practice,

AND

2. Positive clinical impact
   The device is expected to provide a significant positive clinical impact on patients or public health, for a life-threatening or irreversibly debilitating disease or condition, by either of the following:
   • Offering a significant positive clinical impact on patients or public health compared to available alternatives and the state of the art,
     
     OR
   • Fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.

The guidance also explains how to interpret each criterion. Manufacturers are expected to describe the current state of the art and identify relevant alternatives for the same indication (including disease stage/subgroup) as well as justifying any exclusions using EU-appropriate standards and clinical guidance.

How to Obtain Designation

FTo receive BtX designation status, manufacturers must request an opinion from an expert panel. Expert panels are defined and established as per MDR 2017/745 Article 106. They are selected by the European Commission (EC) based on their scientific, clinical, and technical expertise.  Expert panels provide independent opinions and scientific/technical advice on high-risk and orphan devices to manufacturers, notified bodies, member states, the MDCG, and the EC to help shape related guidance and standards.

The process and documentation requirements for seeking expert panel opinion have not been finalized. The EMA is expected to publish more detail before the pilot program starts. What is known is that manufacturers can make the request early in device development and, as per the BtX guidance, expert panels will aim to issue a BtX status opinion within 60 days and prioritize these reviews against their other workloads.  Once a conclusion is reached, the Secretariat (administrative support for expert panels) notifies the MDCG. Devices that receive a positive opinion are then described as BtX-designated going forward.. Manufacturers are expected to describe the current state of the art and identify relevant alternatives for the same indication (including disease stage/subgroup) as well as justifying any exclusions using EU-appropriate standards and clinical guidance.

Advantages of BtX Designation for Manufacturers

BtX designation is intended to give manufacturers a more predictable and better-supported path from early development through certification and provide real-time feedback on critical path data gathering.  The main advantage is the early alignment with expert panels, competent authorities, and notified bodies so that manufacturers can de-risk the clinical plan, carry out other key pre-market testing, avoid late cycle surprises, and keep review timelines moving. Below are some examples of benefits across the development lifecycle:

Pre-certification support during conformity assessment: notified body prioritization and tools like rolling interactions to reduce timeline uncertainty, potential use of the MDR expert panel pathway where applicable, and support through certification and ongoing surveillance activities

• Early support prior to and at designation: expert panel input on whether BtX criteria are met, plus regulatory support from national competent authorities (NCAs) once designation is confirmed
• Post-designation support through verification and validation and post-market planning: priority expert panel advice on clinical strategy and development plans, NCAs prioritizing clinical investigations, earlier and structured notified body interactions, and favourable cost considerations for small-to-medium enterprises
• Pre-certification support during conformity assessment: notified body prioritization and tools like rolling interactions to reduce timeline uncertainty, potential use of the MDR expert panel pathway where applicable, and support through certification and ongoing surveillance activities

Considerations for Manufacturers During Pre-Market Development

Pre-clinical

The guidance provides extensive coverage of considerations to BtX developers for pre-clinical testing and building technical documentation. The guidance touches on:

• Risk management file
• IVD development
• Medical devices containing artificial intelligence (AI)
• Biocompatibility
• Bench testing
• In silico modeling and simulation
• Pre-clinical literature research
• Usability
• Long-term non-clinical studies (e.g., shelf-life testing)
• Manufacturing process considerations

As an example, let’s look at BtX considerations for risk management. Due to the innovative nature of BtX devices, real-world data may be limited early in the risk management process. Risk acceptance criteria for new hazards should be based on what is currently considered acceptable in clinical practice, even if the likelihood of harm cannot be accurately estimated. As clinical results become available (through studies or in post-market), key assumptions and expected event rates should be checked and then updated over time.

Clinical

For pre-market clinical investigations, manufacturers should have a clinical evaluation plan (CEP) that clearly defines the intended patient benefit and outcomes, how safety and residual risks will be assessed, and how benefit–risk acceptability will be evaluated against current clinical practice. To support timely patient access, clinical investigations may focus on gathering sufficient safety and short-to-medium term performance data, with the expectation that this will be followed by post-market clinical investigations and other PMCF/PMPF (post-market clinical/performance follow-up) activities to confirm longer-term safety and performance.

Once on the market, manufacturers need to follow through on post-market commitments made to their notified body during conformity assessment, especially if their CE certificate includes specific conditions or provisions. These obligations may include PMCF/PMPFstudies within defined timelines and enhanced post-market surveillance and monitoring with updates to clinical and performance data. All of this is used to provide assurance and confirmation of the safety and performance of the BtX in real-world use throughout the device’s expected lifetime.

References

European Medicines Agency -> Medical Devices page, Announcement of Breakthrough Designation Pilot.  https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices

MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746. Released December 2025. https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf

FDA Breakthrough Devices Program. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

European Commission proposal to amend regulations (EU) 2017/745 and (EU) 2017/746 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=comnat:COM_2025_1023_FIN